Ribavirin

Zydus Lifesciences Limited
Human Prescription Drug
NDC 65841-603

Ribavirin is a human prescription drug labeled by 'Zydus Lifesciences Limited'. National Drug Code (NDC) number for Ribavirin is 65841-603. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Ribavirin drug includes Ribavirin - 400 mg/1 . The currest status of Ribavirin drug is Active.

Drug Information:

Drug NDC:	65841-603
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Ribavirin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ribavirin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Zydus Lifesciences Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Film Coated
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	RIBAVIRIN - 400 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	05 Dec, 2005
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA077094
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Zydus Lifesciences Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	248109 597718 597722 790286
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0365841129076
UPC stands for Universal Product Code.
NUI:	N0000175459 N0000175466
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	49717AWG6K
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Nucleoside Analog Antiviral [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Nucleoside Analog Antiviral [EPC] Nucleoside Analog [EXT]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
65841-603-07	56 TABLET, FILM COATED in 1 BOTTLE (65841-603-07)	05 Dec, 2005	N/A	No
65841-603-14	60 TABLET, FILM COATED in 1 BOTTLE (65841-603-14)	05 Dec, 2005	N/A	No
65841-603-17	28 TABLET, FILM COATED in 1 BOTTLE (65841-603-17)	05 Dec, 2005	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Ribavirin ribavirin ribavirin ribavirin crospovidone (15 mpa.s at 5%) ferric oxide yellow hypromelloses magnesium stearate polyethylene glycol, unspecified povidone talc titanium dioxide ferric oxide red silicon dioxide cellulose, microcrystalline light pink to pink round zc19 ribavirin ribavirin ribavirin ribavirin ferric oxide yellow hypromelloses magnesium stearate polyethylene glycol, unspecified povidone talc titanium dioxide ferric oxide red silicon dioxide cellulose, microcrystalline light pink to pink capsule zd;07 ribavirin ribavirin ribavirin ribavirin crospovidone ferric oxide yellow hypromelloses magnesium stearate polyethylene glycol, unspecified povidone talc titanium dioxide ferric oxide red silicon dioxide cellulose, microcrystalline light pink to pink capsule zc56 ribavirin ribavirin ribavirin ribavirin crospovidone ferric oxide yellow hypromelloses magnesium stearate polyethylene glycol, unspecified povidone talc titanium dioxide ferric oxide red silicon dioxide cellulose, microcrystalline light pink to pink capsule zd;08

Package Label Principal Display Panel:

Ndc 65841-046-03 in bottle of 168 tablets ribavirin tablets , 200 mg r x only 168 tablets ndc 65841-603-07 in bottle of 56 tablets ribavirin tablets , 400 mg r x only 56 tablets ndc 65841-632-07 in bottle of 56 tablets ribavirin tablets , 500 mg r x only 56 tablets ndc 65841-129-07 in bottle of 56 tablets ribavirin tablets, 600 mg r x only 56 tablets ribavirin tablets, 200 mg ribavirin tablet ,400 mg ribavirin tablet 500 mg ribavirin tablet 600 mg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.